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The European Commission’s (EC) Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) have been the most significant developments for medical device manufacturers willing to enter the European market. These regulations will allow the EU (European Union) regulators to have the required control and oversight of the medical devices entering into the market. The MDR and IVDR...

In recent times, it has been observed that high number of generic drugs are being approved by the United States Food and Drug Administration (US FDA). In parallel, there are also instances of Refuse to Receive (RTR) from the health authority. It might be due to missing or misleading information provided in the Abbreviated New Drug Application (ANDA) Submissions. Though the ANDA applicants are...

Are you a manufacturer of Prescription and Over the Counter (OTC) drugs? Then it is obvious that you are aware of the US Consumer Product Safety Commission (CPSC) regulations under which certain consumer products, including many prescription and OTC drugs are subject to special packaging standards, including Child-Resistant Packaging (CRP) Statements in drug labels. Referring to the same, the...

Though scheduled to take place from March 29, 2019, the Brexit has now postponed to October 31, 2019. The decision is assumed to give more time to the United Kingdom (UK) and the European Union (EU) to agree upon the terms of the UK leaving the EU.

Until now, the EU regulations directly affected the cosmetic products that are distributed in the UK. However, with the Brexit in scenario...

Do you know? To rely on each other’s Good Manufacturing Practice (GMP) inspections pertaining to human medicines, the European Union (EU) and the United States (US) have signed a Mutual Recognition Agreement (MRA) in 1998. However, despite a series of actions and progressive discussions, it was never operational. But the talks which began in 2014 led to revision of Annex in 2017. As a result,...

In July 2019, the European Directorate for the Quality of Medicines and Healthcare (EDQM) has announced that eCTD format shall be mandatory for all Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) applications including notifications, revisions, renewals and new applications. The announcement was made as part of the revised roadmap (2016-2020) for electronic...

To place a cosmetic product successfully in a market, manufacturers are required to decode and comply with the cosmetic regulations of the target country. While some countries follow the global cosmetic regulations, others have their own set of regulations established to monitor the products.

The Food Safety and Standards Authority of India (FSSAI) has issued a draft regulation pertaining to the safety standards of infant nutrition. In India, most of the nutritional products for infants with Inborn Errors of Metabolism (IEM) are imported from foreign countries. With the FSSAI’s new proposal for regulations, companies in India are expected to be able to manufacture IEMs locally. The...

Aligning with all the global health authorities, the Jordan Food and Drug Administration (JFDA), too, has started accepting marketing authorization submissions in electronic common technical document (eCTD) from March 1, 2019. The new format – JO eCTD Format – has similar elements of other health authorities eCTD formats? Obviously not.

Over the past few decades, Pharmacovigilance (PV), has been instrumental in detecting, assessing, understanding and preventing adverse events. In the due course, drug manufacturing organizations have implemented safety and PV systems with due diligence to stay compliant with Health Authority (HA) requirements.

The new Regulatory requirements enforced by HAs directed organizations to...